Quality Engineer II (QE II) at TriMed Inc – Valencia, California

Position Overview
TriMed is seeking a Quality Engineer II to support the quality and compliance of our medical device products and manufacturing processes. In this mid-level role, you will independently lead investigations, support new product development, and partner cross-functionally to drive continuous improvement across the Quality Management System (QMS).

This position is ideal for a hands-on quality engineer who thrives in a regulated medical device environment and enjoys balancing compliance, problem-solving, and cross-functional collaboration.

What You’ll Do

• Independently support and maintain the QMS in compliance with FDA 21 CFR Part 820, ISO 13485, and internal procedures

• Lead nonconformance investigations and CAPAs, ensuring timely and effective root cause resolution

• Provide quality engineering support for new product development, including design reviews, design transfer, and V&V activities

• Partner with Manufacturing and Operations to resolve production quality issues and drive process improvements

• Review and approve Device History Records (DHRs), batch records, and inspection results

• Lead Material Review Board (MRB) activities and disposition of nonconforming material

• Support risk management activities in accordance with ISO 14971

• Participate in internal, supplier, and regulatory audits; support audit readiness and responses

• Perform statistical analysis and trend quality data to identify improvement opportunities

• Support validation activities (IQ/OQ/PQ) for processes, equipment, and software

• Collaborate with Supplier Quality on supplier performance and corrective actions

• Mentor junior quality staff and support continuous improvement initiatives

Required Qualifications

• Bachelor’s degree in Engineering or a related technical field (or equivalent experience)

• 3–5 years of quality engineering experience in medical devices or regulated manufacturing

• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971

• Experience with CAPA, nonconformance investigations, and root cause analysis tools (5 Whys, Fishbone, FMEA)

• Experience supporting design controls and/or manufacturing quality

• Strong analytical and problem-solving skills

• Ability to work independently and cross-functionally

Preferred Qualifications

• Experience with PPAP and APQP

• Experience leading moderate NPI quality projects

• Lean or Six Sigma training or certification

• Experience supporting supplier quality activities

• Advanced statistical analysis experience

Travel & Work Environment

• Approximately 20% travel

• On-site role in Valencia, CA

• Relocation assistance is not available for this position

• Office environment

Why Join TriMed
At TriMed, you’ll work on meaningful medical device products in a collaborative, quality-driven environment. We value continuous improvement, cross-functional partnership, and professional growth.

Benefits may include:

• Medical, dental, and vision insurance

• 401(k) with company match

• Paid time off and holidays

• Professional development opportunities

TriMed, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.